The present invention relates to individualized, customized and personalized solid dosage products having combined doses of one or more drugs that may have a tailored dissolution profile, more particularly to solid dosage products comprising one or more drugs and various sensors or other devices; and to a system and method for the monitoring and calibration of a global network of production units and machines manufacturing the solid dosage products, as well as the real-time monitoring and qualifying of the solid dosage products being produced.
Combining one or more small molecule active ingredients, e.g., active pharmaceutical ingredients (APIs) such as drugs, into one delivery system is becoming a generally accepted approach to providing enhanced treatment of certain diseases or as a method for increasing compliance with, or timelier uptake of, a second drug which complements the first drug, Currently these combinations are manufactured by a pharmaceutical company or a compound pharmacy as a unitary pill or tablet having fixed concentrations of each drug in the final product, often referred to as a polypill, A distributor may then ship supplies of each finished product to a dispensing group such as a pharmacy and/or an end-user. Then, based on a script written by a healthcare provider or under the direction of a healthcare provider, the pharmacy dispenses these tablets, capsules, pills, ointments, and the like to the patient. To be financially worthwhile for a drug manufacturer, a particular drug/dosage permutation would need to prove suitable for a large number of people. As a result, currently manufactured polypills lack much individualization and are genericized so as to capture a greater percentage of the population. Nonetheless, personalized polypills may be manufactured through custom-compounding by a pharmacist; however, very few pharmacies offer such a service.
A further limitation of current polypills is that commercially available medicines are generally available having active ingredients in only a few discrete doses. Consumers need to take one or more tablets of an available dosage so as to roughly receive a desired amount of the active ingredient. In cases where delivery of a precise dose is paramount, such as for highly potent actives, drugs with a narrow therapeutic index, or pediatric formulations (where the dose is based on body mass), the commercial tablets may need to be physically split or otherwise divided prior to administration. However, dividing tablets may result in inaccurate and unknowable amounts of active ingredient within each of the various resultant pieces. As such, consumers can only assume that they are getting the desired amount of active ingredient, but may, in fact, be under-dosing or over-dosing when consuming one piece of the divided tablet.
Another drawback to current medications and its utilization is the poor adherence to treatment regimens by patients. As many as half of all patients do not adhere faithfully to their medication regimens resulting in more than $100 billion spent each year on avoidable hospitalizations. For patients with coexisting conditions who take multiple medications prescribed by multiple physicians, there is also a vital need to reconcile the prescribed regimen with what a patient is actually taking and to understand why there is a difference between the two. However, optimizing and reconciling medications requires substantial investments of time by a skilled health care practitioner, as well as electronic data sharing among practitioners, neither of which is widely available in today's model of health care delivery. Moreover, there are also numerous other factors that affect adherence at the individual level, including lifestyle, psychological issues, health literacy, support systems and side effects of the medications. Indeed, patients' personal attributes probably have the strongest influence on adherence. Thus, engaging, supporting and monitoring patients to improve adherence may improve health outcomes.
Accordingly, there exists a need for a system, method and product harnessing the rapidly converging features of 3D printing/additive solid dosage drug manufacturing, digital medicine with embedded sensors and electronic devices, and personalized medicine dosing. The present invention addresses these and other needs.